Published on 28 Mar 2024 on Zacks via Yahoo Finance
Syndax (SNDX) Gets FDA Priority Tag for Leukemia Drug NDA
Syndax Pharmaceuticals SNDX stock rose 7.6% on Mar 27 after it announced a day before that the FDA had granted a priority review to its new drug application (NDA) for pipeline candidate revumenib. The NDA seeks approval of revumenib, a first-in-class menin inhibitor, for the treatment of patients with relapsed/refractory acute leukemia harboring a KMT2A rearrangement.
The FDA’s targeted action date is Sep 26, 2024. The NDA filing is being reviewed under the FDA's Real-Time Oncology Review Program (RTOR).The RTOR program facilitates efficient engagement between sponsors and the FDA, historically leading to expedited approvals.
The NDA was based on data from the AUGMENT-101 study.At the protocol-defined interim analysis, the study met its primary endpoint with a notable complete remission (CR) or a CR with partial hematological recovery (CRh) rate of 23% among the 57 efficacy evaluable patients in the pooled KMT2Ar acute leukemia population.